The Hennepin Healthcare Research Institute's (HHRI) Berman Center () has a current opening for a full-time Clinical Trials Assistant to support Dr. Gavin Bart's clinical research being conducted at Hennepin Healthcare's HCMC department of Addiction Medicine.

This is a hybrid role where time will be split between telework and having a consistent onsite presence in downtown Minneapolis, MN.

POSITION SUMMARY:

The Clinical Trial Assistant (CTA) is responsible for assisting the Project Manager(s) and other research staff by performing operational tasks associated with the conduct and coordination of clinical trials. The position will provide support to the trial team in the day-to-day tasks involved in planning, execution and close out of clinical trials.

ESSENTIAL JOB FUNCTIONS:

• Assists Project Managers (PM) and Study Coordinators (SC) in collecting trial status information from collaborators, synthesizing and reporting trial progress information.
• Assists PM/SC in preparing, finalizing and reproducing informational documents for assigned clinical trials e.g. operational manuals, newsletters, team-meeting minutes, Q&A documents, etc.
• Assists PM/SC with written communication (e.g. form design, instruction for job function, draft cover letters)
• Interfaces with PM/SC and Data Manager to review and follow up on outstanding queries.
• Tracks collection of key protocol-specific parameters (e.g. pharmacokinetic specimens, imaging studies) and, when applicable, coordinates shipment to appropriate centralized processing center.
• Assists PM/SC to prepare for training meetings & Investigator meetings.
• Prepares regulatory documentation, visit report review, and contact information for various spreadsheets and/or trial management databases.
• Receipt, review (for completeness and internal data consistency) and tracking of data received from clinical sites.
• Assists the PM/SC in the proper filing, maintenance and archival of study documents according to ICH GCP guidance and internal standard operating procedures.
• Assists PM/SC in preparing and tracking of Investigation Product (IP) for packaging distribution and re-supply to designated countries/CRO for assigned clinical trial(s).
• Coordinates generation and allocation of necessary administrative (non-drug) trials supplies among participating sites.
• Assists PM/SC with regards to study related finances (e.g. investigator payments, purchase orders, payment request forms).
• Works with various international and national vendors/ partners.
• Participant interaction as necessary.

EMPLOYMENT STANDARDS:

Education/Experience:
Any equivalent combination of education and experience that provides the required knowledge and skills is qualifying. Typical qualifications would be completion of some college and six (6) months experience in a related area and/or in research.

Skill, Knowledge & Ability (SKA):

Requires interaction with a diverse population. Must demonstrate effective interpersonal and communication skills (verbal & written) and have proven organizational and documentation skills. Self-motivated and detail-oriented, ability to handle multiple tasks and strong organizational skills is important. Adept with computer systems particularly MS Word, PowerPoint & Excel. Previous REDCap use and experience maintaining data integrity, and knowledge of medical terminology a plus. Knowledge of the clinical trial process (including regulatory management is favorable. Should display a high standard of attendance, punctuality, confidentiality, and time management.

AA/EOE of Minorities, Women, Disabilities, Veterans